The use of endoscopes for diagnostic and therapeutic purposes is well known in the medical arts. Various types of endoscopes are available for various particular applications. For example, upper endoscopes are utilized for the examination of the esophagus, stomach, and duodenum; colonoscopes are utilized for the examination of the colon; angioscopes are utilized for the examination of various blood vessels; brochioscopes are utilized for examination of the bronchi; laparoscopes are utilized for examination of the peritoneal cavity; and arthroscopes are utilized for the examination of various joint spaces.
Although endoscopes provide tremendous advantage in the diagnosis and therapy of many medical conditions, contemporary endoscopes are limited in their capability for repeated use. In order to prevent the transmission of various pathogens, it is necessary to sterilize the endoscope between uses. This is of particular concern in contemporary times because of the threat of such vital infections as HIV and hepatitis B.
The sterilization of contemporary endoscopes presents several substantial disadvantages. First, the endoscope must be manufactured to withstand such sterilization. That is, the endoscope must be formed of materials which will not degrade in the presence of those sterilizing agents in contemporary use. This inherently requires that more expensive materials and manufacturing techniques be utilized and that the fiber optic image bundle be adequately isolated from or compatible with such sterilizing agents.
Second, thorough and proper sterilization of the endoscope requires particular care and is consequently a time-consuming operation. Of course, when the endoscope is being sterilized, it is not available for diagnostic and therapeutic use. Because of the high cost of endoscopes and the consequent lack of availability of spares, the down-time necessitated by sterilization represents lost income for the medical facility. This loss of income increases the cost of performing endoscopic procedures.
Third, even with the use of such effective sterilizing agents as glutaraldehyde, adequate sterilization of the endoscope cannot be assured. This is of particular concern when the endoscope has a working channel or other such difficult-to-clean portions. Furthermore, the use of such toxic materials as glutaraldehyde presents a hazard to the patient in that tissue irritations may result from inadequate flushing of the sterilizing agent from the endoscope. Additionally, special equipment such as a ventilated hood, is required in the use of such toxic sterilization agents, thus increasing the cost of performing such procedures.
For endoscopes having working channels, the currently accepted method of sterilization involves the use of a gas sterilization procedure wherein the endoscope is exposed to ethylene oxide gas sterilization protocol for a period of approximately twenty-four hours. As will be recognized, this involves an extended amount of time during which the endoscope is not available for diagnostic and therapeutic use. As with glutaraldehyde, ethylene oxide gas is extremely toxic. Therefore, exposure to personnel must be prevented and traces of the gas must be removed from the endoscope prior to its use to prevent tissue irritation.
It would also be beneficial to provide a disposable endoscope sleeve wherein the cost of the fiber optic bundle is eliminated from the cost of the sleeve, since only the sleeve need be purchased for each use. The fiber optic bundle is a one-time purchase. Thus, a new, sterile sleeve is purchased and used with the existing fiber optic bundle for each procedure.